GE Healthcare recalls SIGNA Creator and Explorer MRI systems due to risk of incorrect patient orientation in scans, potentially causing flipped images.
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
GE Healthcare is recalling SIGNA Creator and SIGNA Explorer MRI systems because a button error can cause scans to show flipped patient images. This might lead to misdiagnosis if the system misinterprets the patient's position during imaging.
The "Patient Orientation" button can be accidentally pressed instead of the "Save RX" button. This causes the system to save a patient orientation that doesn't match their actual position, resulting in images that are incorrectly annotated or flipped.
MRI technicians and patients using GE's SIGNA Creator or Explorer systems. Those who have recently run scans with these machines may be at risk of incorrect image interpretation.
Check if your MRI system is labeled SIGNA Creator or SIGNA Explorer. These systems were sold by GE Healthcare for medical imaging.
Ensure you are not accidentally pressing the "Patient Orientation" button when intending to click "Save RX" during scans.
GE Healthcare has become aware that the "Patient Orientation" button may be accidentally clicked instead of the "Save RX" button, causing incorrect patient orientation in scans.
Incorrect patient orientation can lead to flipped images, which might cause misdiagnosis if the system misinterprets the patient's position during imaging.
Check if your MRI system is labeled SIGNA Creator or SIGNA Explorer, as these are the affected models.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2058-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2058-2021 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
